NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	13356-08-6
Chemical Name	Fenbutatin oxide
Substance ID	m-nite-13356-08-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water due to the water solubility result of 0.0127 mg/L measured (HSDB (Access on June 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an organic compound containing oxygen (but not fluorine or chlorine), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	On the basis of 2 reported LD50 values of 2,631 mg/kg (JMPR (1977)), 4,400 mg/kg (EPA RED (1994), JMPR (1992)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification). The category was revised due to the revision of the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	On the basis of a reported LD50 value of > 2,000 mg/kg (EPA RED (1994)) for rabbits, it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	On the basis of 3 reported LC50 values (4 hours) of 0.072-0.074 mg/L (JMPR (1992), EPA RED (1994)), 0.14, 0.23 mg/L (JMPR (1992)) for rats, it was classified in Category 2. The category was revised due to the revision of the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It is reported that in a skin irritation test in rabbits, it was mildly irritating (EPA RED (1994)), and in a skin irritation test using experimental animals (described as mammals, but species is unknown) it was irritating (HSDB (Access on June 2016)). Therefore, it was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is reported that in an eye irritation test in rabbits, it was severely irritating (EPA RED (1994)), and in an eye irritation test using experimental animals (described as mammals, but species is unknown) it was severely irritating (HSDB (Access on June 2016)). It was classified in Category 2A because irreversible lesions are not described.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	It is reported that a skin sensitization test using guinea pigs (Buehler test) was negative (EPA RED (1994)), but there is only one datum of negative. Therefore, it was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a micronucleus test using bone marrow cells of mice was negative (EPA RED (1994), JMPR (1992)). As for in vitro, bacterial reverse mutation tests were negative, and for cultured mammalian cell tests, gene mutation tests were negative and a chromosome aberration test was negative (EPA RED (1994), JMPR (1992)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In carcinogenicity tests in which this substance was administered by feeding to rats for two years and mice for 18 months, a dose-related increase in tumors was not observed (JMPR (1992)). As the classification by other organizations, ACGIH classified organic tin compounds as A4 (ACGIH (7th, 2001)). Therefore, the substance was classified as "Classification not possible" for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In two and three generation reproductive toxicity studies (2 litters/maternal animal of each generation) with diet administration to rats, in a two generation study, even administering to parental animals until general toxicity expression occurred (reduced weight gain, decreased food consumption), no effect on fertility in parental animials and only slight effects in offspring (lower body weights by weaning) were observed. However, in a three generation study, in the high-dose group (300 ppm), along with general toxicity effects (lower body weights, hyperactivity, and irritability), reduced litter size was found in F1b maternal animals as reproductive effects, and decreased survival rate in F3a and F3b offspring during nursing and the decreased relative testicular weights in the F3b male pups were observed as developmental effects in next generation (JMPR (1992)). On the other hand, in development toxicity tests by gavage administration to pregnant rats or pregnancy rabbits during organogenesis period, at the dose where maternal toxicity (rats: reduced body weight gain, diarrhea; rabbits: decreased body weights, anorexia, abortion) were found, embryo/fetus toxicity such as increase in pre-implantation loss in rats, increase in post-implantation loss and increase in litters with no live offspring in rabbits was observed (JMPR (1992)). As above, it was classified in Category 2 for this hazard class because reproductive/developmental toxicity was observed at dose where general toxicity occurred in parent animals. 　Besides, the Category was assigned at this time because information of newer year than the information used in the previous classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is no data of a single exposure to this substance in humans. As for experimental animals, it is reported that in a single inhalation exposure test using rats, necrosis of bronchiolar epithelium, lung congestion and edema, and lesions in renal tubule epithelium were observed at a dose within a guidance value range of Category 1 (JMPR (1992)). Form the above, it was classified in Category 1 (respiratory organs, kidney). Besides, in the previous classification, the liver and testis were adopted as target organs on the basis of the report that massive fatty changes in the liver and reduced spermatogenesis were observed in a single oral exposure test using rabbits (JMPR (1977)), but as for effects on the testis, it is reported that effects were not found in a follow-up experiment which added control groups (JMPR (1992)). As for effects on the liver, detailed information such as a number of animals, whether necropsy result is that of dead animal or survival animal are unknown. From the above reasons, the classification was revised.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information in humans. 　As for experimental animals, 3-month or 2-year repeated dose toxicity studies using rats dosed by feeding, 5-week or 2-year repeated dose toxicity studies using dogs dosed by gavage, a 21-day repeated dose toxicity study using rabbits dermally applied, and so on were carried out. However, no finding to be available for the evidence for GHS classification was observed in any of the studies (JMPR (1992)). 　Therefore, it was classified as "Classification not possible" due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	From 24-hour LC50 = 0.0008 mg/L for crustacea (Daphnia magna) (ECETOC TR91, 2003), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Due to being not rapidly degradable (BIOWIN), and NOEC (unknown time) = 0.31-0.61 ppb for fish (Oncorhynchus mykiss) (U.S.EPA: RED, 1994), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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